Chapter 5122-2 Grievances; Death; Psychotropic Medication; Etc
(B) As used in this chapter, "RPH" shall mean "regional psychiatric hospital."
(A) The purpose of this rule shall be to establish procedures for the chief executive officer (CEO) of a regional psychiatric hospital (RPH) to apply for and manage funds of clients receiving intensive and specialized services or forensic inpatient services in those RPHs. The CEO shall only apply to become representative payee of a client's funds after all other avenues to obtain an appropriate representative payee have been pursued to no avail.
"Representative payee" means a CEO who has been designated to receive a RPH client's funds and who is responsible to expend the monies for the benefit of the client in accordance with the regulations of those agencies providing the monies. Such agencies can include: federal civil service retirement; public employees retirement system; railroad retirement; social security administration - aged; social security administration - disabled; school employees retirement system; school teachers retirement system; veteran's administration compensation, or pension.
(C) Proper use of representative payee funds:
(1) Funds the CEO receives shall be used for the benefit and well-being of the client.
(2) The CEO is responsible for ensuring that the client is involved in determining his or her needs and that those needs are met.
(3) The client's treatment team shall document that at least quarterly a needs assessment has been done, that the client was involved in that assessment, that items needed are obtained and delivered to the client, and that the client has been informed of the amount of funds available to meet needs. The client must be informed of any per diem charges.
(4) At any time the client is entitled to know the amount of funds available, and to have those funds expended for current needs.
(D) Proper expenditure of representative payee funds:
(1) To meet the personal needs of the client which can aid in the client's recovery or discharge from the RPH or will improve living conditions while there, for example:
(a) Money for spending or for a canteen fund up to fifty dollars per month. Additional funds may be authorized by the client's treatment team based on the client's needs;
(b) Well-fitting clothes and supplies for personal grooming;
(c) Eyeglasses, dentures, hearing aids, dental care or other medical prosthesis, if not reimbursable by some third-party payor;
(d) Transportation costs for client to visit relatives or places that may help lead to recovery; and
(e) Reasonable transportation costs for a close relative to visit if a visit would be in the client's best interest and the client agrees.
(2) Depending upon the personal circumstances of the client, it is possible that one hundred per cent of funds could be spent on personal needs. The department expects that monthly funds available be expended on the personal needs of the client.
(E) Investments and accrual of funds:
(1) It is a high priority of the department that adequate invested funds be accumulated for the client's discharge, thus facilitating return to community living. These accumulated funds can also be used to establish a burial fund if the client dies while in the RPH.
(2) When a CEO becomes a client's representative payee, a fund shall be established and regularly added to from each month's check until a minimum amount of five hundred dollars has been reached. If the client's treatment team foresees a future discharge need greater than five hundred dollars, the regular addition to this fund should continue until the amount of combined funds reaches one thousand five hundred dollars as described in this paragraph.
(a) When investing funds to meet the immediate discharge needs of a client or to secure burial, these funds must be kept in individual federally insured interest bearing accounts.
(b) When funds are so invested, the CEO shall ensure that accumulation of principal and interest does not disqualify the client from health or welfare benefits that might otherwise be available to the client unless there is documented exception by the CEO. Principal, interest and the money available in the client's business office account (including the current month's check) should not exceed one thousand five hundred dollars. If the client's account balance exceeds one thousand five hundred dollars, the excess should be applied to spend-down such as personal needs items or hospital per diem charges.
(c) The CEO shall document that an assessment of needs upon discharge has been made, including consultation with community placements regarding normal and anticipated client placement needs.
(d) In most cases, the CEO will be requesting the proper agency to designate a new representative payee when discharging a client. However, the CEO, as representative payee, has some responsibility to provide for the current needs of the client until the designation is changed. Therefore, these invested funds and future monthly funds can be expended at the time of discharge and following discharge until a new representative payee is designated. The CEO should inform the client's community case manager or the prospective representative payee what unused funds are still available for use upon request. Until the RPH representative payee status has been changed, the CEO remains accountable through documentation for expenditure of these funds and should therefore require proper documentation for funds disbursed for the client's use at the time of discharge, and after discharge but before official transfer of the representative payee status.
(F) Other acceptable client expenditures:
(1) School expenses;
(2) Special rehabilitation or medical equipment expenses if not reimbursed by some other third-party payor;
(3) Insurance premiums;
(4) Current payments on a house in which the client has an interest;
(5) Tax payments;
(6) If all basic needs of a client are being met, some funds may be used to help support a spouse, child, or parent dependent under state law, and
(7) In some cases, a group of clients are allowed to purchase in common some specific items, for example, social/recreational equipment. If this type of purchase is needed, prior written approval of the funding agency is required.
If the CEO is not sure whether a proposed special needs expenditure is proper, it should be cleared with the funding agency.
(G) CEO reporting responsibilities as representative payee:
(1) The representative payee must, within seven days, report to the agency providing benefits to the client any changes that may affect benefit payments such as:
(a) Client enters or leaves RPH;
(b) Client stops or starts working (no matter how small the earnings are);
(c) A client has a change in income or resources;
(d) RPH is no longer responsible for the client; or
(e) Client's treatment team determines client is capable of assuming responsibility for his/her own funds.
(2) The representative payee must, within seven days, report to the agency providing benefits to the client certain events such as:
(a) A disabled person's condition improves whereby reasonable gainful employment is possible;
(b) Custody of a child changes;
(c) Client starts receiving another benefit or has a change in the amount; or
(d) Client plans to go outside the United States for thirty days or more.
The CEO shall ensure that responsibility for fulfilling these reporting requirements is assigned to appropriate staff and that such reporting occurs regularly and promptly.
(H) Requirements when the CEO stops being the representative payee, or if the client dies:
(1) To avoid any unnecessary or lengthy interruptions of funds, the CEO is responsible for notifying the proper agency in advance if the RPH no longer intends to act as payee.
(2) Advance notification must allow time to locate and select a new representative payee. The CEO cannot select or approve the new representative payee.
(3) When the proper agency has approved a new representative payee, generally the CEO must turn over to the proper agency all invested funds, including principal and interest, as well as cash on hand. In some cases, however, the CEO may be asked by the agency to turn over all such funds to the client or to the new representative payee.
(4) When a CEO has requested a change of representative payee status, upon discharge of a client, the CEO may continue to expend funds on behalf of the client until a new representative payee has been designated.
(5) If the client dies, at that point any remaining or invested funds, including principal and interest, belongs to his or her estate. The funds must be given to the legal representative of the estate for distribution or otherwise handled in accordance with state law. In some instances there are insufficient funds to meet immediate burial costs and the court handling the estate may order the RPH to disburse funds for a certain purpose at that time and to disburse remaining funds according to further instructions. The CEO should comply with only court orders regarding disposal of all estate funds upon the client's death.
(I) Evaluating the need to continue as representative payee for the client.
(1) At least twice a year, depending upon the client's length of stay, the individual treatment team shall evaluate whether the client really needs to continue having a representative payee. If it is their opinion that the client no longer needs a representative payee, and the client agrees, the RPH should submit such information to the proper agency for its consideration.
(2) When the RPH discharges a client who has a representative payee (whether the representative payee is the CEO or another person), the individual treatment team, when notifying the social security administration of discharge, shall state their opinion as to whether the client has a need for continuation of the representative payee.
(J) CEO accounting for representative payee funds:
(1) As representative payee, the CEO has a fiduciary relationship to the client.
(2) Appropriate records of money received and how it was spent or invested must be kept by the CEO and is subject to audit by the state auditor's office, the department's internal auditors, and auditors from the proper agency designating the CEO as representative payee.
(4) Sometimes the agency designating the CEO as representative payee will require specific reports of its own. The CEO shall comply with these requests.
The CEO shall assure that staff are assigned to properly administer and account for these funds as described in this paragraph.
(K) Department monitoring of CEO duties as representative payee.
(1) The office of fiscal administration shall conduct, at least annually, an audit of representative payee accounts as part of the regular RPH audit. This part of the audit shall review the client's account, the current account billing by the fiscal operations and revenue section (formerly the section of reimbursement services) of the department, and a review of procedures included in this procedure with regard to performance as representative payee. One of the performance criteria used in the department's internal audit will be expenditure of funds for personal needs or documented exceptions authorized by the CEO and that there are properly invested funds which have been used as an appropriate part of discharge planning.
(2) A copy of the findings of the office of fiscal administration during this internal audit shall be forwarded to the CEO, deputy director of hospital services and the department chief financial officer.
(3) If the internal audit report includes deficiencies regarding responsibilities as representative payee, the CEO shall prepare a plan of correction for this and send a copy to the deputy director of hospital services and the department chief financial officer.
(4) When the deputy director of hospital services, has approved the plan of correction for implementation, a copy will be forwarded to the office of fiscal administration to be included for review during the next scheduled audit.
The CEO is responsible for ensuring that training is provided to those RPH staff having responsibility for carrying out the duties of representative payee. Training shall be provided to such personnel on an annual basis. Documentation that all staff having responsibility for carrying out the duties of representative payee receive such training once each calendar year shall be maintained.
Promulgated Under: 111.15
Statutory Authority: 111.15 , 5119.01, 5119.35
Rule Amplifies: 5119.35
Prior Effective Dates: 2-10-1979, 7-1-1980, 2-13-1983, 4-4-1986, 3-4-1991, 2-1-2000, 5-26-2008
(A) The purpose of this rule is to promote individual recovery and provide a means for persons served who have or are receiving regional psychiatric hospital (RPH) inpatient services or persons acting on their behalf to lodge complaints, request mediation, and file grievances and appeals regarding care, treatment, environmental conditions, the exercise of client rights or other aspects of inpatient care or services and to have those complaints, grievances and appeals heard and acted upon in a timely manner, including access to mediation. This rule also reinforces the obligation of all staff to listen to and respond to complaints of persons served.
(B) The provisions of this rule shall be applicable to all RPHs providing inpatient services under the managing responsibility of the department.
(C) The medical director of the Ohio department of mental health and addiction services shall adopt a policy regarding client complaint and grievance procedures at RPHs.
(D) Each RPH may make changes to the client complaint and grievance procedure policy with the approval of the RPH's governing body, the department's client's rights specialist, and the medical director of the department.
(E) The client compliant and grievance procedure policy shall be based on 42 CFR 482.13 and the centers for medicare and medicaid services manual, effective date October 17, 2008.
(F) The client compliant and grievance procedure policy shall be reviewed by the medical director not more than three years after the date of the last review of the policy.
Five Year Review (FYR) Dates: 06/01/2022
Promulgated Under: 119.03
Statutory Authority: 5122.33
Rule Amplifies: 5122.29
Prior Effective Dates: 3/7/1986, 7/27/1990, 12/13/1999, 6/06/2011
Each RPH shall develop and follow a tuberculosis control plan that is based on the risk classification of the facility. The control plan and facility risk assessment shall be consistent with the United States centers for disease control and prevention "guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings, 2005," MMWR 2005, Volume 54, No. RR-17 and any additional requirements set forth by the Ohio department of health in rule 3701-15-03 of the Administrative Code.
Five Year Review (FYR) Dates: 07/12/2023
Promulgated Under: 119.03
Statutory Authority: 5119.10
Rule Amplifies: 5119.10 , 5119.11
Prior Effective Dates: 11/16/78, 07/01/1980, 3/10/00, 07/15/2002, 6/13/09
(A) The purpose of this rule is to establish department policy and guidelines governing the development and implementaton of assessments, treatment plans and discharge plans.
(1) "Basic neurological exam" means an examination of cranial nerves, sensory and motor functions, coordination, and deep tendon reflexes.
(2) "CPST" means community psychiatric supportive treatment service which provides an array of services delivered by community based, mobile individuals or multidisciplinary teams of professionals and trained others. Services address the individualized mental health needs of the client. They are directed toward adults, children, adolescents and families and will vary with respect to hours, type and intensity of services, depending on the changing needs of each individual. The purpose/intent of CPST service is to provide specific, measurable, and individualized services to each person served. CPST services should be focused on the individual's ability to succeed in the community; to identify and access needed services; and to show improvement in school, work and family and integration and contributions within the community.
(3) "Day" means a calendar day, unless otherwise indicated.
(4) "Direct care nursing staff" means, but is not limited to, registered nurses, licensed practical nurses, mental health technicians, and therapeutic program workers.
(5) "Goal" means an expected result or condition that takes time to achieve, that is specified in a statement that provides guidance in establishing intermediate objectives directed towards its attainment.
(6) "Long-term view" means the life situation the patient would like to attain in the next three to five years. Usually described in the patient's own words, the long-term view includes all elements that are important to the patient. This may include living arrangements, vocational/educational activities, relationships, and other factors that are important to the quality of life desired by the patient.
(7) "Objective" means an expected result or condition that takes less time to achieve than a goal, is stated in measurable terms, has a specified time for achievement, and is related to the attainment of a goal.
(8) "Physical disabilities" means conditions such as deaf/hard-of-hearing, visual impairment, and/or other physical limitations in what would be considered normal physical functioning that may affect an individual's access to treatment, and that needs to be considered in the overall assessment process, and in the development of an individual's treatment plan.
(9) "Physical examination" means an examination of a patient by a physician including, but not limited to, all the items indicated on "History of Physical Illness" and "Physical Examination" forms designated by the department.
(10) "Physician" means a person licensed under the laws of this state to practice medicine.
(11) "Psychiatric examination" means an examination of a patient by a psychiatrist, or a physician privileged by the facility to conduct such examinations, including, but not limited to, all the items indicated on the "Psychiatric Examination" form designated by the department.
(12) "Psychiatrist" means a licensed physician who has satisfactorily completed a residency training program in psychiatry, as approved by the residency review vommittee of the American council on graduate medical education, the committee on graduate education of the American osteopathic association, or the American osteopathic board of neurology and psychiatry, or who, as of July 1, 1989, has been recognized as a psychiatrist by the Ohio state medical association or the Ohio osteopathic association on the basis of formal training and five or more years of medical practice limited to psychiatry.
(13) "Psychologist" means an individual who holds a current license under Chapter 4732. of the Revised Code which authorizes the practice of psychology.
(14) "Recovery" means a personal process of overcoming the negative impact of a psychiatric disability despite its continued presence.
(15) "Registered nurse" means an individual who holds a current license issued under Chapter 4723. of the Revised Code which authorizes the practice of nursing as a registered nurse.
(16) "Social worker" means a person who uses the application of specialized knowledge of human development and behavior, and social, economic and cultural systems in directly assisting individuals, families, and groups to improve or restore their capacity of social functioning, including assessment, counseling, and the use of social work interventions and social psychotherapy.
(17) "Treatment plan" (also known as "plan of care") means a written statement of specific, reasonable and measurable goals and objectives for an individual established by the treatment team, in conjunction with the patient, with specific criteria to evaluate progress towards achieving those objectives.
(18) "Treatment team" means a team comprised of the patient, patient's family as defined and authorized by the patient, psychiatrist, or physician so privileged by the facility, registered nurse, social worker, and other appropriate personnel (such as activity therapist, CPST worker, interpreter, readers, dietitian, occupational therapist, pharmacist, psychologist, and others as appropriate) based on patient needs and standard-setting agency requirements.
The RPH shall be responsible for conducting a complete assessment of each patient, including a consideration of the patient's abilities, strengths, stage in the recovery process, problems, and needs, and the types of services required to meet those needs in the least restrictive setting. Assessments shall contain a statement of individual strengths, and anticipated treatment interventions and recommendations. The assessment process shall pay careful attention to the uniqueness of individual patients, such as the presence of any physical disabilities, cultural differences, and/or religious preferences. To the fullest extent possible, each assessment shall be conducted in the patient's preferred method of communication; for deaf/hard of hearing patients, an interpreter shall be used to communicate unless the patient has expressed a preference for an alternative form of communication. See ODMH policy MD-10 "Providing Services to Deaf and Hard-of-Hearing (Deaf/HOH) Patients in ODMH Hospitals." The assessments shall include, but not be limited to, the following areas: physical, mental, behavioral, social, recreational, financial, housing, vocational, recovery stage, and when appropriate, educational, legal, risk, nutritional, cultural, and spirituality. Information from relevant community agencies with whom the patient has been involved in treatment should be used as appropriate in the assessment process. It is understood that, due to a patient's condition, and/or unwillingness to cooperate with an assessment or with certain portions of it, the time frames indicated for assessments may not be met in every instance.
(1) A complete history and physical examination shall be completed on all patients within twenty-four hours of admission. This history and physical examination shall include a medical, alcohol and drug history, and a vision and hearing screening. It shall also include appropriate information about past and current physical disorders, and a basic neurological examination. Phrases like, "gross neurological examination within normal limits", "intact", and "no abnormalities", without any indication of tests performed and their result, are not acceptable.
(2) A psychiatric examination shall be completed and in the patient's medical record within sixty hours of admission.
(3) A nursing assessment by a registered nurse shall be completed, and in the patient's medical record within twenty-four hours of admission.
(4) A social work assessment, including a social history, shall be completed, and in the patient's medical record prior to the development of the comprehensive individual treatment plan.
(5) A psychological assessment shall be provided as appropriate to patient need.
(6) Other patient assessments shall be completed as appropriate, depending on the patient's needs, and standard-setting agency requirements.
(7) The physical and psychiatric examinations and the nursing and social service assessments shall be updated as often as indicated by the patient's changing condition, but in no case less frequently than annually. Other assessments shall be reviewed and updated as appropriate, based on patient need.
(8) Comprehensive physical examinations performed within thirty days prior to admission by a privileged member of the medical staff may be accepted, provided they are reviewed by the physician and are authenticated as still current, or are updated as needed; and provided a legible copy of the examination as authenticated or updated is placed in the patient's medical record within twenty-four hours of admission.
(9) Each RPH shall have a policy relating to needed assessments, or portions thereof, that are refused by the patient or that are deferred for some reason. The policy shall state the manner in which these deferrals or refusals are to be dealt with, and time frames for doing so.
(D) Treatment plan
Each patient shall have developed with the treatment team a treatment plan which is responsive to the treatment needs and recovery process of the patient, based on information provided by the patient, the patient's family/significant others, and assessments by the treatment team. The plan shall include services to be provided to the patient during the inpatient stay and needed services after discharge. Services to be planned for all patients after discharge shall include medication, housing, financial, and when appropriate, vocational and peer support services. This plan shall be developed with the involvement of the patient, and, when appropriate, the patient's family/significant others, and the CPST worker. The active involvement of the patient, any significant others, and the CPST worker, shall be documented. Each treatment plan shall pay careful attention to the uniqueness of individual patients, such as the presence of any physical disabilities, cultural differences, and/or religious preferences. In treatment plan development and implementation, the patient's preferred method of communication shall, to the fullest extent possible, be utilized. The treatment plan shall be developed and implemented as follows:
(1) An admitting/initial treatment plan, based on the intake assessments, shall be developed at the time of admission. This plan may be documented in the physician's admission note, and/or admitting orders. It shall give adequate direction to all relevant staff regarding the treatment regimen to be followed pending the development of the comprehensive treatment plan. This plan shall be reviewed and updated as indicated.
(2) Each patient shall have a comprehensive treatment plan developed by the treatment team. This plan shall be developed no later than five calendar days from admission, counting the day of admission as day one. This plan shall be based on the assessments referred to in paragraphs (C)(1) to (C)(7) of this rule, and upon identified patient abilities, strengths, stage in recovery process, problems, and needs. In most instances this plan will be a further evolution of the plan begun at the time of admission, but based now on more comprehensive assessment information.
(3) Each patient's comprehensive treatment plan shall be reviewed and updated by the treatment team as often as is indicated by the patient's condition, and his/her progress, or lack thereof, in achieving the goals of treatment. It is to be emphasized that the patient's changing condition, and his/her progress, or lack thereof, in moving towards recovery and the achievement of established treatment goals, is the primary determinant of the need for a review and update of the individual treatment plan. However, in no case shall the interval between reviews and updates exceed the following:
(a) Thirty days from the date of the comprehensive treatment plan;
(b) Every thirty days for the next two months of receiving RPH services;
(c) Every sixty days thereafter during the first year of receiving RPH services;
(d) For patients who are in the RPH beyond one year, at least every ninety days for the duration of receiving RPH services.
(4) Each review and update of the treatment plan shall include a reassessment of the individual's diagnosis, and principal behaviors necessitating inpatient care. Changes shall be made in the treatment regimen, as appropriate, based on the patient's changing condition. The active participation in this entire process of the patient, any significant others, and the CPST worker, shall be encouraged and documented.
(E) Treatment plan contents
Each individual treatment plan and reviews or updates shall contain:
(1) A substantiated diagnosis;
(2) Clearly identified patient abilities, strengths, problems, needs, and stage of recovery drawn from the assessments, and any updates, thereof, that will be addressed in treatment;
(3) Clearly stated and measurable goals and objectives relative to the identified abilities, strengths, problems and needs, including recovery-related issues;
(4) Estimated time frames for the achievement of each goal and objective;
(5) Specific treatment methodologies, with their frequencies, focus, and duration, that will be used in an effort to achieve each stated objective;
(6) Individual names of staff responsible for carrying out, or assuring the carrying out, of each treatment method referenced in paragraph (E)(5) of this rule. The professional discipline shall be clearly indicated;
(7) Criteria for transition to the community, that is, clearly stated patient mental and behavioral status sufficient to allow continued treatment as needed in a community setting;
(8) Specific plans, or recommendations, for post-discharge services;
(9) The patient's involvement in and expressed concerns about the treatment plan;
(10) The patient's long-term view.
(F) Discharge planning Discharge planning should start the day of admission. Upon admission, or linkage to a provider organization, the CPST worker, if applicable, and the community provider organization shall be notified, and invited to participate in, and kept fully apprised of plans, including the discharge date.
Appropriate levels of supervision, housing, and peer support services, if appropriate, shall be identified by the treatment team and communicated to the provider staff. If the patient is not able to be discharged within one week after he/she is ready for discharge due to placement problems, the RPH social worker shall inform the RPH social work director/designee. The RPH social work director/designee shall contact the community provider organization to facilitate the discharge. These cases are reviewed by the RPH utilization review committee. Regular meetings between the RPH chief clinical officer and the mental health center chief clinical officers and their staffs need to be held to address cases that cannot be resolved by the social work directors.
(G) Patient access to medical records
(1) Pursuant to division (A)(5) of section 5122.31 of the Revised Code, a patient shall, upon request, be granted access to his/her medical record unless clear treatment reasons, i.e., likely to endanger the life or physical safety of the patient or others, are documented in the individual treatment plan and physician progress notes restrict such access. Examples of clear treatment reasons include:
(a) The information is about another person and the RPH determines that patient review would cause sufficient harm to another individual to warrant withholding; or
(b) Review by the patient could be reasonably likely to endanger the life or physical safety of the patient or anyone else.
(2) If restricted, the areas in the record from which the patient is restricted to view shall be noted; the non-restricted areas are still accessible to the patient. The patient's written treatment plan shall specify the treatment designed to eliminate the restriction.
(H) Authorization of individual treatment plans
The names of all team members actually participating in the development and/or review and update of the treatment plan shall appear on the treatment plan. The individual treatment plan and each review and update thereof shall be signed by a psychiatrist, or a physician so privileged by the RPH. A psychiatrist, or a physician so privileged by the RPH, shall assume primary responsibility for supervision and evaluation of each patient's ongoing care and treatment. The patient shall participate in the development of his/her treatment plan and shall be asked to sign it.
(I) Implementation of treatment plans
Treatment plan progress notes shall be completed for patients. The frequency of the notes is determined by the condition of the patient. Progress notes are written at least weekly or more frequently if clinically indicated. Such notes shall indicate the treatment interventions carried out in relation to a specific problem or goal on the treatment plan, and shall contain a careful assessment of the patient's progress in accordance with the stated goals and objectives on the treatment plan, and subsequent updates thereof. They shall also contain any recommendations for the continuation of or modifications in the patient's treatment regimen. All such entries shall be signed and dated by the staff member and the professional discipline shall be clearly indicated. In addition, direct care nursing staff shall complete regular notes. These notes shall be daily for the first week of admission. After the first week, while no required frequency is given, the notes shall be frequent enough to give a clear picture of the patient's clinical status and his/her response to the active treatment interventions.
(J) Treatment plan monitoring
Individual treatment plans governed by this policy shall be monitored by the RPH quality assurance/ improvement program. Results of the monitoring activity shall be distributed as appropriate both to inform staff persons with a need to know, and in order to assure prompt and effective corrective action on all identified deficiencies.
Promulgated Under: 111.15
Statutory Authority: 4731., 5119.01, 5122.28, 5122.29
Rule Amplifies: 5119.01, 5122.28, 5122.29
Prior Effective Dates: 12-15-1975, 7-1-1980, 6-7-1993, 2-1-2000, 9-30-2002
(A) The purpose of this rule is to ensure safe quality patient care by establishing standards that govern all aspects of medication practices within regional psychiatric hospitals (RPHs). Medication practices shall reaffirm patients' rights to receive appropriate medication treatment and to participate actively in treatment decisions.
(B) This rule applies to all RPHs inpatient settings operated by the Ohio department of mental health and addiction services. Community support network (CSN) programs operated by an RPH shall meet the requirements established under rule 5122-29-05 of the Administrative Code.
(1) "Administration" means the direct application of a single drug to the body of a patient either by injection, inhalation, ingestion, or any other means.
(2) Allied health professional means an advanced practice registered nurse or physician assistant licensed under the laws of this state.
(4) "Computerized physician order entry" and "CPOE" mean the computer program by which a physician or other licensed/certified prescriber can order a medication.
(5) "Dispensing" refers to the final association of a medication with a particular patient pursuant to a lawful prescription of a physician or other licensed/certified prescriber, and assuming responsibility for the activities involved in filling the prescription.
(6) "Emergency" means an impending or crisis situation which creates circumstances demanding immediate actions for prevention of injury to the patient or others, as determined either by a physician or registered nurse or physician assistant.
(7) "Hazardous medication" means a medication which is potentially genotoxic, carcinogenic, teratogenic, or can cause developmental toxicity, if improperly handled. A list of these medications is published by occupational safety and health administration (OSHA) and updated yearly.
(8) "High risk medication" means a medication which has potential side effects which are known or suspected to cause adverse, potentially life-threatening reactions or lasting serious health impairment.
(9) "Informed consent" means a process that requires a prescriber to give a patient or legal guardian all information necessary to make an informed decision to either undergo or refuse a proposed treatment or medication, including the following components: nature of the treatment or medication; the potential benefits, risks and/or possible side effects or consequences associated with taking or not agreeing to the recommended treatment or medication; any alternative treatments available to the patient; and determination that the patient has the capacity to give or withhold informed consent.
(10) "Medication/drug" means a natural or chemical substance, that exerts a pharmacological effect, intended to be used for the purpose of treatment, prevention, or diagnostic studies of illness.
(11) "Medication reconciliation" means the gathering of data on medications that were prescribed prior to admission and using the data in the selection of medications that are prescribed during the patient's hospital stay. Upon discharge/transfer a list of medications currently prescribed is also shared with the next provider of services.
(12) "Medication with abuse potential" means a medication, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V of "The Controlled Substance Act" or other non-controlled medication with recognized potential for abuse.
(13) "Physician" means a person licensed under the laws of this state to practice medicine.
(14) "Prescriber" means a person licensed/certified under the laws of Ohio to prescribe medication. This includes physicians, dentists, optometrists, podiatrists, advanced practice registered nurses/nurse practitioners with prescribing authority and physician assistants with a certificate to prescribe.
(15) "Prescribing" means an order for medication(s) issued.
(16) "PRN order" means an order for a medication that is given only when a patient manifests a specific clinical condition and consents to take the medication.
(17) "Prescription drug" means a medication that shall be dispensed only upon a prescription, and/or includes on the manufacturer's label, the wording: "Rx only" or the statement: "Caution: federal law prohibits dispensing without prescription."
(18) "Psychotropic medication" means medication which has specific and intended effects on the central nervous system functions and which is ordinarily used to alter disorders of thought, perception, mood, or behavior.
(19) "Standing orders" means an established routine or special order from a prescriber and approved by the CCO, which is applicable to the general population of a unit/ward as opposed to an individual.
(20) "Telephone order" means an order transmitted via the telephone.
(21) "Verbal order" means an order spoken aloud by a prescriber in the presence of the person authorized to receive the order.
(22) "Verification" means the professional clinical review of a patient's medication profile by a pharmacist for dose, schedule, medication allergies, drug-drug interactions, drug-food interactions, and drug-disease interactions prior to the dispensing of a new medication.
(D) Prescribing practices.
(1) All medications shall be prescribed as deemed medically appropriate pursuant to a physical and psychiatric evaluation. Prescribing practices shall be in compliance with state/federal laws, and standards of accrediting/certifying entities.
(2) All medications shall be prescribed consistent with department policies and clinical practice guidelines. Medications shall not be prescribed or administered in quantities which prevent a patient from participating in psycho-social treatment.
(3) Each patient's medication regimen shall be reviewed and evaluated by the attending physician at time intervals established by RPH policies, but at least monthly. Documentation of this evaluation shall be made in the patient's medical record.
(4) When the prescribing of two medications from the same psychotropic medication class is indicated, the reasons for prescribing more than one medication from the same class shall be documented by the prescriber in the patient's record. If the concomitant use of three antipsychotic medications occurs for greater than sixty days, a review shall be conducted by the RPH CCO/designee.
(5) RPH policies and procedures shall address high risk medications, hazardous medications, and medications with abuse potential.
(6) Medications may be prescribed on the basis of a telephone order only when received and recorded by a registered nurse, licensed practical nurse or registered pharmacist. All telephone orders must be countersigned, dated and timed, after review by the prescriber or covering prescriber, within forty-eight hours, unless a shorter time interval is specified within RPH policy. The order shall be written down and then "read back" by the RN/pharmacist to the prescriber to ensure the correctness of the order.
(7) Telephone orders shall be limited to the specific circumstances described in RPH policy.
(8) Verbal orders may only be used in an emergency situation. Verbal orders shall be signed, dated and timed by the prescriber within one hour.
(9) PRN medication orders must specify indication for its use. If more than one PRN medication is ordered for the same indication, the orders must contain clear instructions for the relationship between their administrations (e.g., conjointly, in what sequence, etc.).
(10) Medication orders shall be time-limited in accordance with applicable state and federal laws and regulations, but in no case shall medication orders exceed three hundred sixty-five days. (See appendix A to this rule). Renewal of the medication orders shall be done by the prescriber in a timely fashion to avoid missed doses and other complications.
(11) For patients who lack a payer source for medication, the prescriber may order up to a fifteen-day supply of medication to be dispensed to the patient at discharge. For patients with a payer source, the prescriber may order up to a three day supply to be dispensed at discharge, along with a prescription for up to thirty days of medication to be filled after discharge. Larger amounts may be given with CCO approval.
(12) Standing orders shall be prohibited, except as approved by the RPH medical staff organization.
(13) The prescriber shall perform medication reconciliation as part of the admission and discharge processes, and throughout the hospitalization as appropriate.
The prescriber shall document in the progress notes of the patient's medical record justification of the use of medications. Documentation shall include but is not limited to:
(1) Rationale for the use of each prescribed medication, including the increase/decrease in dose or form of the same medication;
(2) Rationale for a change to a different medication;
(3) Rationale for cessation of a given medication; and
(4) Periodic review and evaluation of the patient's response to the medication regimen.
(F) Pharmacy/dispensing practices
(1) The pharmacy is responsible for procurement, distribution and drug control within the RPH. Pharmacy operations shall comply with state and federal drug laws, regulations, and standards of accrediting or certifying entities. The pharmacy shall maintain an up-to-date policy and procedure manual.
(2) The pharmacy shall receive medication orders through the CPOE program or in written form, in accordance with the Ohio drug laws. Procedures for receipt of medication orders shall be specified in RPH policies. The pharmacy shall dispense medications only upon the order of a prescriber.
(3) The pharmacy shall maintain a medication profile for each patient and a pharmacist must clinically review this profile prior to the dispensing of the medication, in the process of verification. Medication profiles will be in accordance with Ohio drug laws, RPH policies, and standards of accrediting or certifying entities. When deemed necessary, the pharmacy shall notify the appropriate clinician(s) of problems existing within a medication regimen. This notification shall be documented. When a drug is not available in a particular dose, the pharmacist may substitute with other dosage strengths available as long as the total combined doses equals the dose ordered by the physician/prescriber. The prescriber will not be required to enter/write a new order as no new order is generated. Example: "valproic acid five hundred mg is substituted with valproic acid two hundred fifty mg two tablets."
(4) The pharmacy may have semi-professional or clerical assistance in activities which do not require professional judgment. These activities must be supervised by a licensed pharmacist.
(5) Patient-specific prescription drugs will be dispensed, packaged, stored, and labeled as required by Ohio drug laws. Prescription drugs that are emergency supplies or floor stock must be accompanied by appropriate accountability records, and shall be issued, stored, and secured in accordance with Ohio drug laws. Prescription drugs issued as floor stock shall not be in excessive quantities and shall be periodically reconciled with the corresponding accountability sheets.
(6) Pharmacies that provide a contingency drug cabinet/automated dispensing machine (ADM) shall maintain the cabinet/(ADM) in a secure area other than the pharmacy. RPH policy shall specify personnel who may access the contingency supply and address accountability of the medications.
(7) The pharmacy is responsible for the safe and secure storage of all medication. All areas within the RPH where medications are stored will be inspected on a monthly basis. Inspections will be documented and discrepancies identified, communicated, and corrected. Medications must be properly stored in all areas of the RPH with respect to appropriate space, temperature, light, moisture, segregation, and security.
(8) The pharmacy will dispense medications in compliance with department policies, directives, guidelines, and protocols.
(G) Record keeping
The pharmacy will maintain appropriate and current licenses with the Ohio board of pharmacy and the U.S. drug enforcement administration and maintain records as required by Ohio and federal drug laws to ensure a complete audit trail of accountability.
(H) Clinical responsibilities
(1) RPH pharmacists shall participate in clinical activities regarding medications. RPH policies and procedures shall define these clinical activities.
(2) An RPH may establish additional policies which outline clinical pharmacy practices consistent with the Revised Code and under the supervision of the CCO or designee.
(I) Administration practices
(1) All medication orders shall have the authority of a privileged and licensed prescriber's signature or other means of order authentication when CPOE is used.
(2) Medications may be administered to patients only with a documented informed consent, except: .
(a) In emergency situations (see OhioMHAS guideline MD-11 "Guidelines for OhioMHAS Informed Consent"); or
(b) When administering over the counter medications; or
(c) As authorized by a court.
(3) After verification of the identity of the patient, medications shall be administered only by a clinician appropriately licensed by the state and deemed competent to do so by the RPH .
(4) Sound and prudent professional judgment shall be exercised in the administration of medications.
(5) Medication must always be verified with the order prior to transcription and administration although medication may be administered prior to pharmacist review of the order in emergency situations, as identified by the terms "emergency" or "stat" in the order.
(6) Self administration of medication by a patient shall be permitted only when a specific order is written by the patient's prescriber and as specified by RPH policy.
(7) Medication shall be administered by the established standard drug administration schedule of the RPH unless otherwise specified by the prescriber.
(8) Medication errors of level 1 or greater (as defined by OhioMHAS policy MD-03 "Medication Errors") and/or adverse drug reactions (ADR) shall be immediately reported to the patient's physician (or covering physician) and documented per department policy.
(J) Education/competency/performance improvement
(1) Physicians, other prescribers, nurses, and pharmacists shall hold current, valid, professional licenses and be in good standing with their licensing boards. All of these disciplines shall assist in educating direct care personnel regarding appropriate medication practices. The content of this rule shall be a part of employee orientation. Physicians, other prescribers, nurses, and pharmacists shall provide education and information relating to medication to staff, patients, and family.
(2) The competency of each physician, other prescriber, nurse, and pharmacist shall be monitored, evaluated and documented on an ongoing basis as part of the RPH performance improvement program and consistent with RPH policies, procedures, and competency plans.
(3) Each RPH shall develop and implement a performance improvement program that addresses significant areas of medication standards of practice.
(K) Quality assurance/performance improvement
(1) RPHs shall establish mechanisms that make patient safety in the area of medication use a high priority.
(2) RPHs shall establish mechanisms to encourage a culture of safety that includes:
(a) Reporting of ADR, near miss errors and all medication errors. Reporting of medication errors shall not result in any retaliatory action against the reporting person.
(See OhioMHAS policy MD-03, "Medication Errors").
(b) Analysis of medication use processes through failure mode effects analysis to reduce or eliminate potential errors.
(3) RPHs shall establish mechanisms in coordination with the hospital services pharmacy and therapeutics committee to disseminate to clinicians current information on prevention of errors and potentials for improvement of medication use.
(1) The chief executive officer of each RPH shall be responsible for implementation of this rule through RPH policy.
Five Year Review (FYR) Dates: 06/10/2016 and 08/25/2021
Promulgated Under: 119.03
Statutory Authority: 5119.10
Rule Amplifies: 5119.10 , 5119.11
Prior Effective Dates: 7/1/1980, 2/10/1990, 9/1/2000, 12/9/2002, 10/10/2010. 1/3/2013
(A) The provision of a physically and psychologically safe environment is a basic foundation and requirement for effective mental health treatment. Treatment environments free of coercive interventions and violence promote positive, trusting relationships and facilitate treatment and recovery.
Physical restraint and seclusion are emergency interventions intended to prevent injury. They are not a form of therapy and may actually be traumatizing to a patient. We thus strive continually to reduce and minimize the use of seclusion and restraint. We recognize that these emergency interventions are to be used only by trained and competent staff and as a last resort in order to eliminate dangerous and potentially harmful behaviors and to preserve safety and dignity. All patients should be assessed for any past exposure to these emergency interventions along with possible alternative interventions based on patient preference and experience.
The fundamental goal of inpatient care is to facilitate recovery from serious mental illness, especially from acute exacerbation of illness that may affect judgment, perception and emotion. Quality inpatient care includes a physically and psychologically safe environment for both patients and staff. The policy and preference of the department is for more positive, supportive and less intrusive measures, including counseling, positive relationships, and creating a therapeutic environment that facilitates treatment and recovery.
To reduce incidents that may lead to injuries, staff should employ a multi-modal approach and interdisciplinary, trauma-informed, proactive intervention treatment perspective. ODMH policy MD-19 "Proactive Positive Interventions" describes appropriate early staff intervention to maximize safety; recommended actions when symptoms of aggression erupt; and necessary debriefing, communication and medication reevaluation after an episode of aggression. In the final section, the policy outlines a staged process for the clinician role in the treatment paradigm for safe and quality care, including psychotropic medication specifics.
Best practices include careful early assessment and documentation of a person's history with a particular emphasis on past trauma or abuse. Seclusion and restraint are extremely intrusive measures to control potentially harmful behavior and to preserve safety. At times, restraint is experienced by patients as a recapitulation of past experience(s) of abuse. Special attention must be given to anticipate, and prevent if possible, or minimize restraint in such cases. The experience of seclusion and restraint is stressful for both staff and patients, requiring debriefing and support for these individuals. The purpose of this rule shall be to define and establish uniform procedures governing the safe, humane, and appropriate use of seclusion and restraint consistent with this philosophy, standards of quality treatment and respect for the rights of patients.
(B) The provisions of this rule shall be applicable to all regional psychiatric hospital inpatient settings operated by the department of mental health.
(2) "Clear treatment reasons" means that permitting the patient to participate will present a substantial risk of physical harm to the patient or others or will substantially preclude effective treatment of the patient. If a restriction is imposed for clear treatment reasons, the patient's written treatment plan shall specify the treatment designed to eliminate the restriction at the earliest possible time.
(3) "Direct care personnel" means personnel with special training, competency and experience in assessing and treating persons with mental illness and whose primary responsibility is for such functions.
(4) "Emergency" means an impending or crisis situation which demands immediate action for preservation of life or prevention of serious bodily harm to the person or others as determined by a licensed physician or registered nurse.
(6) "Mechanical supports" means items used for the purpose of achieving proper body alignment, position and balance. Mechanical supports shall not be considered restraints under this rule when used in this manner. Examples include orthopedic-prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm.
(7) "Physical restraint" means any method, or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. For purposes of this rule, physical restraint refers to:
(a) "Manual restraint" means physically holding an individual to restrict an individual's ability to move his or her legs, arms, head, or body, freely.
(b) "Physical restraint with devices" means any method of restricting a person's freedom of movement, physical activity, or normal use of his or her body, using an appliance or device manufactured for this purpose.
(c) "Prone restraint" means all items or measures used to limit or control the movement or normal functioning of any portion, or all of an individual's body while the individual is in a face-down position for an extended period of time. Prone restraint includes manual or physical restraint with devices.
(d) "Transitional hold" means a restraint involving a brief physical positioning of an individual face-down for the purpose of quickly and effectively gaining physical control of that individual in order to prevent harm to self and others, or prior to transport to enable the individual to be transported safely.
(8) "PRN order" means a practitioner's written order for a medication, treatment, or procedure which is only carried out when an individual patient manifests a specific clinical condition.
(9) "Quiet time" means a voluntary procedure through which a patient removes him/herself to an unlocked area from a situation which is too stimulating, in an effort to regain self-control.
(10) "Seclusion" means confinement of a patient alone in a room, locked or unlocked, in which that patient is physically prevented from leaving for any period of time.
(11) "Treatment plan" means a written statement of specific, reasonable and measurable goals and objectives for an individual established by the treatment team, in conjunction with the patient, with specific criteria to evaluate progress towards achieving those objectives.
(12) "Treatment team" means a team comprised of the patient, patient's family as defined and authorized by the patient, psychiatrist, or physician so privileged by the facility, registered nurse, social worker, and other appropriate personnel (such as activity therapist, CPST worker, interpreter, reader, dietitian, occupational therapist, pharmacist, psychologist, and others as appropriate) based on patient needs and requests, and standard-setting agency requirements.
(D) It is the policy of the department that seclusion and restraint shall be applied in a safe and humane manner as measures of last resort. The goal of seclusion and restraint use is to assist the patient in regaining self control and maintaining dignity while reducing the risk of injury to patients and staff. The use of seclusion and restraint shall be consistent with nationally recognized standards for quality treatment and applicable laws.
(1) Regional psychiatric hospital (RPH) policies for seclusion or restraint must require that these measures shall:
(a) Only be imposed to ensure the immediate physical safety of the patient, a staff member, or others, and must be discontinued at the earliest possible. time;
(b) Not employ a drug or medication when it is used as a restriction to manage the patient's behavior, or restrict the patient's freedom of movement, and is not a standard treatment or dosage for the patient's condition;
(c) Be employed as a last resort when lesser restrictive measures aimed at assisting a patient to control his or her behavior have failed;
(d) Not be used as coercion, discipline, or punishment; for the convenience of staff; or longer than clinically necessary;
(e) Be employed using the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff or others.
(f) Not cause injury to the patient;
(g) Not be used in place of more appropriate treatment interventions;
(h) Be used in a manner that best protects and maintains the dignity and individuality of each patient, and considers:
(iii) Developmental issues;
(v) History of physical or sexual abuse, or other trauma;
(vi) Medical conditions;
(vii) Physical disabilities; and
(viii) If individual is deaf, hard-of-hearing, or whose primary spoken language is other than English.
(i) Be ordered only by physicians;
(j) Be used to allow the greatest possible comfort of the patient; and
(k) Be vigorously supervised and monitored using individual medical record reviews and aggregate data reviews as part of an ongoing and systematic quality improvement program.
(2) Position in restraint. RPH policies and procedures shall ensure that:
(a) The use of prone restraint is prohibited.
(b) A patient shall be placed in a position that allows airway access and does not compromise respiration, regardless of the method of restraint utilized.
(c) The use of a transitional hold shall be subject to all of the following requirements:
(i) Applied only by staff who have current training on the safe use of this procedure, including how to recognize and respond to signs of distress in the patient.
(ii) Applied only in a manner that does not compromise breathing, including, but not limited to the following:
(a)The weight of the staff shall be placed to the side, rather than on top of the patient. No transitional hold technique shall allow staff to straddle, or bear pressure or weight on, the patient's back while applying the restraint, i.e. no downward pressure may be applied.
(b)No soft device, such as a pillow, blanket or other item, shall be placed under the patient's head or upper body; and
(c)No transitional hold technique shall allow placing the patient's or staff's arms under the patient's head, face, or upper body.
(iii) All staff involved in the procedure must constantly observe the patient's respiration, coloring, and other signs of distress, listen for any complaints of breathing problems, and immediately respond to any observed concerns with the intent to ensure that the patient is safe and suffers no harm.
(iv) Transitional hold may be applied only for the reasonable amount of time necessary to safely bring the patient or situation under control and to ensure the safety of the individuals involved; and
(v) After conclusion of the transitional hold, the patient shall be assessed at least every fifteen minutes, for two hours, to assure that the patient is not in need of medical attention. The results of each assessment shall be documented.
(3) RPH restraint and seclusion policies shall incorporate the following:
(a) Restraint shall be applied with concern for good body alignment and comfort of the patient, and recognition of any medical conditions;
(b) Seclusion may be employed only in rooms which contain proper temperature control, ventilation and lighting, a visual panel of safety glass for staff to make observations, a safe and sanitary environment void of wall/ceiling fixtures and sharp edges, electrical outlets; and include a bed, mattress, bed sheets and pillow unless the patient's condition warrants their removal. Removal requires a physician's written order and documentation of rationale for removal, however, a nurse may initiate their removal and then obtain the physician's order within sixty minutes after the removal.
(4) Steel cuffs or other restraining devices may be used by security staff for custody, detention, and public safety reasons and are not considered behavioral restraints. The use of steel cuffs to restrain a patient on a unit is prohibited.
(1) RPHs may distinguish between manual or physical restraint with devices in policy consistent with regulating and accrediting authorities and this rule.
(2) Approved restraints are indicated below and are to be used in accordance with the limitations stated in this rule.
(a) Physical restraints with devices:
(i) Padded leather cuffs, vinyl flexicuffs, waist/wrist cuffs (pads), and two- and four-point belts and cuffs;
(ii) Mittens securely fastened around the wrist with a tie;
(iii) Any item which inhibits bending of the elbow, wrist, or fingers that was devised by clinical staff to prevent patients who engage in chronic self-mutilation from inflicting injury to themselves and cannot be readily removed by the patient. These items must be approved prior to use by the CCO and the team designated to review behavioral therapy at the RPH;
(iv) Helmets only if the helmets are of an approved type and affixed in such a manner that removal or choking cannot be easily accomplished by patients;
(v) Mechanical supports used for restraint rather than support purposes (e.g., soft ties, geri chairs, and tie jackets) shall be considered physical restraint devices under this rule.
(vi) Items used for medical, surgical or dental procedures shall not be considered restraints under this rule.
(b) Manual restraint. A patient may be physically held by staff in either an emergency situation to prevent injury to the patient or others until appropriate physical restraint devices may be applied, or to control for transporting/transferring. Manual restraint is typically applied for only a brief period of time (less than five minutes).
(3) Quiet time shall not be considered restraint or seclusion.
(a) Quiet time may be initiated by either a staff person or the patient;
(b) The use of quiet time may be part of the plan of care and documented in the patient's medical records;
(c) The quiet area/room utilized for quiet time may be the patient's room or a special room or area designated for quiet time;
(d) Special care must be maintained when a suicidal or self-injurious patient is being authorized to use the quiet area/room; and (e) Only one patient is allowed in the quiet area/room at a time.
(4) Personnel designated below shall be the only individuals permitted to implement/employ specific seclusion and restraint techniques cited if they have been trained and are competent to do so:
(a) Direct care and nursing personnel shall be permitted to implement seclusion and restraint only if these employees have successfully completed training programs on minimizing the use of restraint or seclusion and to maximize safety when using seclusion and/or restraint;
(b) RPH security personnel shall implement seclusion and restraint and assist in the use of these interventions when a patient's behavior is beyond the control of nursing or other direct care personnel only if they have successfully completed training programs on minimizing the use of restraint or seclusion and maximizing safety when using seclusion and/or restraint; and
(c) Any employee who has successfully completed training programs on minimizing the use of restraint or seclusion and maximizing safety when using seclusion and/or restraint shall be permitted to assist in the application of restraints.
(1) RPH policies shall
(a) Allow a patient, as part of treatment planning, the opportunity to identify techniques that would help the patient control his or her behavior; and
(b) Consider a patient's advance directive addressing special safety and treatment if seclusion or restraint is warranted.
(a) Any application of seclusion or restraint of a patient shall require a physician's order. Physician orders are obtained beforehand, as much as possible, but in emergent situations, a registered nurse can direct the use of seclusion or restraint (either a physical restraint with devices or a manual restraint) and obtain a physician's order as soon as possible afterward in accordance with paragraph (F)(2)(e) of this rule. The physician must order seclusion and restraint separately. Each order shall be documented and placed in the patient's medical record.
(b) With the exception of orders for the use of mittens and helmets for patient who exhibit self-injurious behavior, each order for seclusion or restraint shall be in force for no longer than one hour for an initial order, or up to two hours for a renewal. A physician shall personally examine the patient and substantiate the need for continuing the use of physical restraint with devices, or seclusion prior to renewing any order.
(c) The CCO or designee must review any episode of seclusion or restraint which exceeds eight hours before another order may be written.
(d) Orders for restraint devices to prohibit self injury including mittens and helmets shall not exceed four hours, and require a face-to-face evaluation by a physician for renewal in accordance with paragraph (F)(6) of this paragraph.
(e) In situations where, after a series of less restrictive interventions have failed and a seclusion or restraint is needed immediately to control the emergency situation, a patient may be restrained or secluded at the direction of a registered nurse without a written physician's order, if the following requirements are met:
(i) A physician shall be contacted by a registered nurse as soon as possible to obtain a telephone order, but no longer than thirty minutes after the initiation of restraint or seclusion;
(ii) The registered nurse shall explain to the patient the reason for seclusion or restraint and the behaviors of the patient which would indicate sufficient self-control to discontinue the measure;
(iii) The registered nurse shall document the physician's telephone order in the patient's medical record; and
(iv) The physician shall personally examine the patient and document in the chart within one hour after giving/receiving a telephone order to:
(a)Substantiate the need for such a measure, including the clinical indications. Documentation should show that the physician considered both the benefits and risks of these measures;
(b)Perform the medical assessment noted in paragraph (F)(3) of this rule; and
(c)Countersign, date and time the telephone order.
(v) When a nurse initiates seclusion or restraint without a physician's order, and the physician, upon examination, does not substantiate the need for such a measure, the seclusion or restraint shall be terminated immediately.
(a)The results of the examination and rationale for not ordering seclusion or restraint shall be documented by the physician.
(b)The CCO or designee shall review all of the documentation related to the seclusion or restraint.
(f) Standing or PRN orders for seclusion or restraint shall not be used.
The physician shall personally examine the patient who has been secluded or restrained in conjunction with writing orders for these interventions. The patient shall be given an explanation of the reason for the restraint or seclusion, and the behaviors of the patient which would indicate sufficient behavioral control to discontinue the intervention. The examination shall include the following unless clinically contraindicated and documented in the patient's record:
(a) An assessment of any physical problems or an unstable medical status that might contraindicate the use of seclusion or restraint. If there are none, the evaluator shall document in the patient's medical record that there are no known contraindications to this seclusion or restraint procedure;
(b) Vital signs including temperature, pulse, respiration, and blood pressure, or documentation if not done, and why;
(c) A review of current medications if the evaluation is conducted by a physician;
(d) Documentation to substantiate the clinical indication for seclusion or restraint use, and that the evaluator considered both the benefits and risks of these measures; and
(e) If the one hour face-to-face evaluation is conducted by a physician other than the attending physician, the attending physician or other licensed independent practitioner responsible for the care of the patient must be consulted as soon as possible.
(4) Rationale for the release from seclusion or restraint shall be documented by the registered nurse or licensed practical nurse in the patient's medical record.
(5) The treating physician shall be contacted as soon as possible if the restraint or seclusion was ordered by another physician.
(6) Patient care and documentation standards.
(a) All prior interventions used before seclusion or restraint shall be documented in the patient's medical record.
(b) To ensure proper safety, body comfort, and circulation of a patient placed in restraints, checks of the patient's condition shall be made by direct care personnel.
(i) Patients placed in restraints or seclusion shall be continuously monitored. Observations of the condition of the patient shall be made and documented in the patient's medical record at least every fifteen minutes or more often if the patient's condition so warrants.
(ii) Appropriate assessments of a patient in restraint or seclusion shall be conducted every fifteen minutes by trained and competent staff, and documented in the patient's medical record. The fifteen minute assessments shall include, as applicable: signs of any injury; nutrition/hydration; circulation and range of motion in the extremities; vital signs; hygiene and elimination; physical and psychological status and comfort; and readiness for discontinuation of restraint or seclusion.
(iii) When a patient is removed from physical restraint with devices, nursing staff shall continue to monitor the progress of the patient and make at least one entry, including vital signs, within two hours in the patient's medical record concerning the patient's status. More frequent monitoring may be necessary if warranted by the patient's condition.
(c) All patients placed in restraint or seclusion shall be visited by a registered nurse or licensed practical nurse no less than every hour to assess the patient. These visits shall be documented in the patient's medical record. This contact may be modified by a physician's order if the patient's need for reduced stimulus outweighs the need for continued medical assessment.
(d) A patient placed in restraint or seclusion shall be provided the opportunity for motion and exercise for at least ten minutes during each two hour period in which these devices are employed. This shall be documented in the patient's medical record.
(e) The patient's medical record shall include documentation of fluids being offered and monitoring for fluid intake and output. Monitoring may be modified by a physician's order if the patient's condition warrants reduced monitoring. The physician's order shall include rationale for the reduction in monitoring of fluid intake and output.
(f) The rationale for each episode of seclusion or restraint shall be clearly documented in the patient's medical record by the physician who examined the patient.
(g) The physician shall specify criteria for discontinuation of seclusion and/or restraint.
(h) With the patient's consent, the patient's family is notified of the initiation of restraint or seclusion.
(7) Conduct debriefings after an incident. (See ODMH policy MD-19 "Proactive Positive Intervention Treatment and Safety").
(a) The goals of debriefing are to:
(1) minimize the negative effects of the incident on all involved individuals; and
(2) identify alternatives strategies to prevent or minimize future occurrences.
(b) Each patient shall be given the opportunity to debrief each episode of seclusion or restraint, unless specifically contraindicated in the treatment plan for clear treatment reasons. As part of the debriefing, the patient shall be given the opportunity to identify techniques that would assist the patient to control his or her behavior. In addition, patient debriefing provides an opportunity to minimize trauma and reestablish the therapeutic staff-patient relationship. Families may also participate in the debriefings at the patient's request.
(c) Each RPH shall develop procedures to debrief staff after an episode of restraint. Conduct a staff debriefing when a physical intervention occurs to:
(i) Assess for any injury;
(ii) Plan next steps for the patient's care and protection for the remainder of the shift;
(iii) Determine how management of the situation could have been handled differently;
(iv) Provide information to patient's treatment team to assist in treatment plan revisions;
(v) The following are examples of questions that may be included in a staff debriefing:
(a)Were there alternative actions that could have been taken to prevent the incident?
(b)Could some intervention earlier in the prodrome have prevented the outcome?
(c)In the case of restraint, could seclusion have been an alternative?
(d)Would it be possible to achieve a better outcome if an assist team were called?
(e)Are we medicating optimally? Is the patient adherent? How do we respond to possible non-adherence?
(f)What environmental changes might minimize the risk of further dangerous behaviors (e.g., room changes, roommate changes, ambient noise, light, or congestion on the unit, access to exits, response to visitors, etc.)?
(8) Monitoring and quality improvement requirements
(a) Each unit shall be responsible for preparing a daily log indicating name of patient, patient number, living unit, time of day in, time of day out, for each episode of seclusion or restraint.
(b) The regional psychiatric hospital CCO or his/her designee and the director of nursing/nurse executive and/or his or her designee shall review, daily, all uses of seclusion or restraint.
(c) The quality improvement review of restraint and seclusion shall include, at a minimum, the following:
(i) A review of the aggregate monthly totals of the use of restraint or seclusion by type, ward, time of day, and other data required in paragraph (F) of this rule;
(ii) The review of any major incidents that resulted in the use of seclusion or restraint;
(iii) Within one business day, the treatment team shall conduct a review of any patient who required any seclusion or restraint. During this review the current treatment plan shall be assessed and revised as needed to contain specific elements that are aimed at reducing the use of seclusion or restraint. All prior interventions shall be reviewed. If successive treatment plan revisions are not successful in reducing the use of seclusion or physical restraint with devices in a clinically reasonable amount of time, consultation from outside the treatment team must be obtained. The department or regional psychiatric hospital behavior therapy committee, the CCO, other treatment teams, private consultants etc. may be sources utilized to conduct a consultation; and
(iv) The findings from the activities under paragraph (F) of this rule shall be reviewed monthly. This review shall identify any trends, increases, and problems. The need for additional training, consultations, or corrective action will be noted in the minutes of that review and forwarded to the CCO for possible action.
(v) The data collected in paragraph (F) of this rule and other related quality improvement review information shall be available to central office.
(d) Each patient, unless specifically contraindicated in the treatment plan for clear treatment reasons, shall be given the opportunity to debrief each episode of seclusion or restraint. As part of the debriefing, the patient shall be given the opportunity to identify techniques that would assist the patient to control his or her behavior. This shall be documented in the patient's medical record.
(e) Each regional psychiatric hospital shall develop procedures to debrief staff after an episode of restraint.
(G) Orientation and training
(1) Each chief executive officer shall be responsible for ensuring that orientation and training programs regarding the use of seclusion and restraint are provided. These programs shall be provided and conducted by appropriate personnel.
(2) Training shall emphasize the use of non-physical crisis intervention, behavioral and other treatment strategies to prevent exacerbation of aggression, and other techniques that will reduce the use of restraints. Special attention shall be placed on the humane use of any restraint technique.
(a) All personnel shall have appropriate training during employee orientation.
(b) All new and existing direct care personnel and regional psychiatric hospital security personnel shall receive training in behavioral and other techniques to reduce the use of seclusion or restraint, and the proper use of physical restraint, manual restraint, and seclusion. This training will be conducted at least annually or more often if indicated by quality improvement reviews.
(c) Upon successful completion of each orientation or training program, a record of this training shall be documented and maintained in each employee's personnel folder.
The chief executive officer of each RPH shall be responsible for implementation of this rule.
Promulgated Under: 111.15
Statutory Authority: 5119.01, 5119.07, 5122-27, 5122-29
Rule Amplifies: 5119.01, 5119.07, 5119.82, 5122-27, 5122-29
Prior Effective Dates: 4-24-1978, 7-1-1980, 1-11-1991, 6-1-2000, 7-15-2002
(A) Purpose (1) The purpose of this rule shall be to establish uniform procedures governing the safe, humane, and appropriate use of mechanical supports consistent with standards of quality treatment and respect for individual autonomy, dignity and rights of patients.
(2) The provisions of this rule shall be applicable to all regional psychiatric hospitals (RPHs) inpatient settings operated by the department of mental health. Community support network (CSN) programs shall meet the requirements established under rule 5122-26-16 of the Administrative Code.
(2) "Mechanical supports" mean items used for the purpose of achieving or maintaining proper body alignment, position and balance. When used for these purposes, they shall not be considered restraints under rule 5122-2-17 of the Administrative Code.
(4) "Occupational therapy assistant" means a person who is licensed or holds a limited permit to provide occupational therapy techniques under the general supervision of an occupational therapist.
(1) Mechanical supports are used infrequently in behavioral healthcare settings.
Mechanical supports are not used for behavioral purposes.
Mechanical supports are not considered restraints.
(2) Mechanical supports are used to achieve proper body position, balance, or alignment and are part of an established treatment plan to address a patient's physical impairment and increase mobility. Mechanical support use is voluntary. Mechanical support devices are generally removable by the patient. Examples of mechanical supports include the use of leg braces to assist a patient to walk or the use of a wedge or back brace to assist a patient to sit upright.
(3) Additionally, mechanical support devices may be used when medically necessary to maintain position, limit mobility, or temporarily immobilize a patient during medical, dental, diagnostic, or surgical procedures.
(4) To assure safe and appropriate use, mechanical support use is addressed in the treatment plan and ordered by a physician with physical therapy/occupational therapy consultation as needed. Mechanical support use is monitored by nursing staff. RPH leadership shall provide oversight to assure safety and quality in accordance with this rule and all applicable CMS and TJC standards.
(1) A physician may order mechanical support devices as part of a patient's treatment plan. The treatment plan should specify nursing monitoring instructions and timeframes. The order shall specify the condition(s) for their use.
(2) Each order for mechanical support shall be in force for no longer than thirty days. A physician shall review and substantiate the need for such items prior to renewing any order and document that review in the patient's medical record.
(3) Mechanical support use shall be reviewed in consultation with a physical therapist or occupational therapist as needed. The following are examples of devices used for mechanical support: prescribed orthopedic devices; protective helmets; bed rails, or devices used to protect a patient from falling out of bed where the bed rail can be easily lowered by the patient; geri chair and tray where the patient can easily remove the tray; waist or torso posey used to maintain posture that can be easily removed by the patient; devices used to permit a patient to participate in activities without the risk of physical harm; medically necessary positioning or securing devices to maintain position, limit mobility, or temporarily immobilize the patient during medical, dental, diagnostic or surgical procedures; hand mitts used to prevent self injury that do not restrict free movement of fingers, and use of hands and wrists.
(4) Because the current definition of restraint does not name each device and situation that can be used to immobilize or reduce the ability of the patient to move his or her arms, legs, body, or head freely, it promotes looking at each patient situation on a case-by-case basis to assure that a device is not being used as a restraint. The use of hand mitts, bed rails, geri chairs, and posey devices may all be considered restraints depending on the situation, purpose, and application of a device or method.
(5) Procedures for assessment and monitoring of the patient shall be detailed in the treatment plan and physician orders. Assessments must occur at least daily and more often if indicated. Patient assessment and monitoring may be done by a registered nurse, physical therapist, occupational therapist or occupational therapy assistant. to assure proper positioning and body alignment. This assessment shall be documented in the patient's medical record.
(6) Training regarding the use of mechanical supports shall be part of employee orientation and repeated in accordance with RPH policy. The RPH shall maintain records of personnel completing training in these areas.
(7) Hospital leadership shall oversee the use of mechanical supports as part of the RPH quality assurance performance improvement program to ensure compliance with this rule and nationally recognized standards for safety and quality.
(8) The chief executive officer of each RPH shall be responsible for the development of guidelines for implementation of this rule.
Promulgated Under: 111.15
Statutory Authority: 5119.01, 5119.07, 5119.82, 5122.27, 5122.29
Rule Amplifies: 5119.01, 5119.07, 5122.27, 5122.29
Prior Effective Dates: 4-24-1978, 7-1-1980, 1-11-1991, 5-25-2000, 7-15-2002
The purpose of this rule shall be to facilitate the development of appropriate behavior therapy interventions in the inpatient services of the Ohio department of mental health (ODMH) hospitals, and to protect the rights of patients involved in behavior therapy.
"Behavior therapy" means the utilization of interventions in which positive reinforcers or regulated interventions (see page 8 of Behavior Therapy Manual) are applied in a systematic and contingent manner in the context of individual or group programs to change or manage behavior or facilitate improved self-control. The goal of behavior management is not to curtail or circumvent an individual's rights or human dignity, but rather to assist the individual in increasing his/her ability to exercise those rights. Prohibited actions may not be implemented under any circumstances (see page 9 of Behavior Therapy Manual).
"Behavior therapy plan/behavior plan" means an agreement negotiated with the person served, and as appropriate, parent or guardian, in which mutually agreeably behavior goals and interventions are specified.
ODMH is committed to ensuring that patients who are recovering from severe mental illnesses have meaningful choices and options. These include behavioral and cognitive behavioral interventions that have demonstrated efficacy. It is the goal of ODMH and each regional psychiatric hospital (RPH) to ensure that these intervention options are available to the patients they serve.
The hospital services behavior therapy committee (HSBTC) and committees at each RPH support the development and implementation of these interventions. These committees are also responsible for promoting proactive positive interventions and for overseeing behavioral and cognitive behavioral interventions to prevent practices that are harmful or abusive to patients, and to protect the rights of patients in these areas of practice.
(A) Hospital services behavior therapy committee(HSBTC)
The HSBTC is responsible for promoting proactive positive intervention and beneficial behavioral and cognitive behavioral interventions and preventing harmful or abusive practices. The committee reports to the medical director of ODMH.
(1) The membership of the committee consists primarily of mental health professionals. The medical director of the ODMH shall appoint all members^ and all members shall serve at the pleasure of the medical director. There will be at least one member from each RPH.. This member shall also be a member of his/her respective RPH behavior therapy committee. One member of the committee will be from the Ohio legal rights service. A consumer who has previously received inpatient services in one of ODMH's RPH's may also be appointed to the committee. The medical director is an ex-officio member of the committee.
(2) The HSBTC will determine its meeting schedule, but will meet at least once each quarter. The medical director will designate an HSBTC manager who will be responsible for coordinating the work of the committee with the medical director, e.g., notifying members of meetings, recording minutes of meetings, posting approved minutes on the ODMH intranet, and coordinating within the ODMH.
(3) The medical director shall appoint a chairperson and a vice-chairperson for the committee. The chairperson and vice-chairperson shall serve a two-year term. The chairperson is responsible for conducting meetings and working with the HSBTC manager to ensure the effective functioning of the committee, and that the decisions of the committee are implemented. The vice-chairperson shall assume all of the duties and responsibilities of the chairperson in the chairperson's absence.
(B) RPH behavior therapy committee (RPHBTC)
(1) Each RPH medical staff organization will have a behavior therapy committee or other committee designated to carry out the functions of the behavior therapy committee. Each RPHBTC will be responsible for promoting behavioral interventions at the RPH that will assist patients in their recovery. The RPHBTC will develop procedures for reviewing and approving all behavior plans. All behavior plans will be reviewed by the RPHBTC. Regulated interventions will not be implemented unless approved by the HSBTC. The HSBTC will monitor, at least monthly, the implementation of any behavior plan involving regulated interventions and will require revision or discontinuation if the plan is not effective.
(2) The RPH chief executive officer shall appoint members and leadership of the RPHBTC upon recommendation of the RPH medical executive committee. One or more members of the RPHBTC will be recommended to the ODMH medical director to serve on the HSBTC. A consumer from outside of the RPH may be appointed to the RPHBTC.
(3) The RPHBTC shall meet at least once each quarter. Minutes shall be kept of all meetings and shall be sent to the RPHBTC manager.
(C) Behavior therapy manual
(1) The HSBTC shall maintain a behavior therapy manual that contains definitions of recommended, regulated, and prohibited behavior therapy interventions and forms for behavior therapy plans. The HSBTC is responsible for maintaining the list of recommended, regulated, and prohibited actions. Interventions and actions may not be added to, deleted from, or changed on the list by the HSBTC unless approved by the medical director. The HSBTC shall submit proposed changes to the medical director.
(2) The behavior therapy manual shall be reviewed and updated at least annually by the HSBTC.
(D) Behavior therapy expertise
Each of the ODMH RPHs shall designate a qualified person as a behavior therapy specialist. The behavior therapy specialist shall be qualified by training and/or experience in behavior therapy, standards of practice, behavioral intervention and evaluation of specific behavioral techniques. The behavior therapy specialist qualifications will be further described in the behavior therapy manual. This person shall be available for case consultation and review, and management of special behavioral interventions, and have interactions with the HSBTC.
Five Year Review (FYR) Dates: Exempt
Promulgated Under: 111.15
Statutory Authority: 5119.10
Rule Amplifies: 5119.10
Prior Effective Dates: 07/01/1980, 01/24/1991, 04/16/2001, 06/01/2003, 05/26/2008, 03/16/2010
(1) To define and establish investigation and reporting mechanisms for both morbidity and mortality events, and sentinel events.
(2) Morbidity, mortality, and sentinel events consist of the following situations:
(a) Death or major permanent loss of function of a patient currently receiving services at an ODMH regional psychiatric hospital (RPH) or community support network (CSN) program:
(b) Death of a former patient within thirty days of discharge from an RPH:
(c) Suicide attempt by a current RPH or CSN patient or within thirty days of discharge from an RPH:
(d) Any serious patient injury or condition that probably resulted from clinical care of lack of clinical care:
(e) Abduction of a patient receiving care, treatment, and services:
(f) Alleged rape of a patient while being treated or on the premises of the RPH or CSN. under the following conditions: staff-witnessed sexual contact: sufficient clinical evidence obtained by the RPH to support allegations of nonconsensual sexual contact: or admission by the perpetrator that sexual contact occurred on the premises.
(1) "Intense analysis" means a performance improvement process used to examine systems and processes in order to identify improvements and risk reduction strategies to prevent morbidity, mortality, and sentinel events. This process shall be used to review morbidity, mortality, sentinel events, and near miss events that do not meet the criteria for a full root cause analysis.
(2) "Morbidity and mortality alert" (M&M alert) means a communication from the ODMH medical director/designee to RPH chief executive officers (CEOs), chief clinical officers (CCOs). clinical nurse managers, and quality improvement directors for the purpose of recommending initial and/or safety actions to minimize risk to patients in all ODMH RPHs and CSNs.
(3) "Morbidity/mortality event" (M&M event) means any type of death (mortality! or situation where, except for the presence of appropriate and effective medical/psychiatric care, the patient would have died (morbidity). :
Morbidity/mortality events include
(a) Death or major permanent loss of function of a patient currently receiving services at an ODMH RPH or CSN:
(b) Death of a former patient within thirty days of discharge from an RPH;
(c) Suicide attempt by a current RPH or CSN patient, or within thirty days of discharge from an RPH;
(d) Any serious patient injury or condition hat probably resulted from clinical care or lack of clinical care.
(4) "Reviewable sentinel event" means the subset of sentinel events that falls within the scope of the joint commission's sentinel event policy and is subject to review by the joint commission. This includes any occurrence that meets the following criteria:
(a) Any event that results in an unanticipated death or major permanent loss of function, not related to the natural cause of a patient's illness or underlying condition (e.g.. a medication error, assault, fall, restraint, or elopement resulting in death or major permanent loss of function);
(b) Suicide of a patient receiving care, treatment, and services in a staffed around-the-clock care setting or within seventy-two hours of discharge;
(c) Abduction of a patient receiving care, treatment, and services;
(d) Alleged rape of a patient while being treated or on the premises of the RPH or CSN. under the following conditions: staff-witnessed sexual contact; sufficient clinical evidence obtained by the hospital to support allegations of nonconsensual sexual contact; or admission by the perpetrator that sexual contact occurred on the premises.
(5) "Root cause analysis" means a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause analysis focuses primarily on systems and processes, not on individual performance. It progresses from special causes in clinical processes to common causes in organizational processes and systems, and identifies potential improvements in processes or systems that would tend to decrease the likelihood of such events in the future or determines, after analysis, that no such improvement opportunities exist.
(6) "Sentinel event" means an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or limb function. The phrase "or the risk thereof includes any "near miss" or process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
(1) ODMH hospital services (HS) morbidity and mortality quality assurance committee (HSM&M committee):
(a) Membership shall consist of the following individuals:
(i) Chair - ODMH medical director/designee;
(ii) ODMH quality assurance/improvement director;
(iii) ODMH clinical safety director within the division of the medical director;
(iv) ODMH chief legal counsel/designee;
(v) ODMH deputy director of HS/designee; and
(vi) Others, as deemed appropriate.
(b) The ODMH HSM&M committee shall serve the following functions:
(i) Review all hospital morbidity, mortality, and reviewable sentinel event reports for completeness;
(ii) Determine whether appropriate policies and procedures were followed in the filing of hospital morbidity, mortality, and reviewable sentinel event reports;
(iii) Determine if any form of in-service education should occur;
(iv) Recommend methods to reduce future incidents to ODMH RPHs statewide through M&M alerts and other mechanisms, as developed;
(v) Develop, review, and revise as needed, the department administrative rule on morbidity, mortality, and sentinel events;
(vi) Determine if a specialized review process or subcommittee should be established to review individual events; and.
(vii) Analyze (i) through (vi) of this paragraph (C)(1)(b) and develop annual reports regarding morbidity, mortality and reviewable sentinel events including trends or patterns of performance.
(c) The committee shall meet at least quarterly;
(d) Meeting minutes and summary reports, as deemed appropriate, will be developed and maintained by the quality improvement director.
(2) Regional psychiatric hospital morbidity and mortality quality assurance committee (RPH M&committee).
(a) Each RPH shall establish an M&M committee/subcommittee under the medical executive committee. The committee shall function as part of the hospital's quality assurance program. The hospital CCO or designee shall chair the committee.
(b) The members of the RPH M&M committee shall be appointed by the hospital CEO and shall consist of at least the following members:
(i) Chair - RPH CCO/physician designee;
(ii) RPH quality assurance/improvement (QA/QI) director;
(iii) RPH risk manager/safety officer/patient safety coordinator/designee;
(iv) RPH nurse executive or registered nurse designee;
(v) RPH CEO or designee from administration; and
(vi) Other RPH staff as needed, depending on the circumstances surrounding the case or because of involvement with the patient's treatment regime (e.g., security department, staff/supervisors, physician, nurse, client advocate, risk manager, pharmacist, medical records administrator, CSN program director/supervisor/staff, etc.).
(c) The RPH M&M committee shall review each morbidity, mortality and reviewable sentinel event as described in section (A)(2) of this rule and document the review on forms maintained securely by the hospital QA/QI director.
(d) Meetings shall be called by the chair of the committee at least quarterly. or as needed. The minutes of the RPH M&M committee meetings shall be maintained securely by the hospital's OA/OI director. Names and titles of all staff present shall be indicated, as well as the date and time of the meeting. If a staff member is representing another staff person, this shall be indicated in the minutes. A copy of the minutes may be requested by the office of quality assurance/improvement in central office.
(3) All proceedings, records, information, data, reports, recommendations, evaluations, opinions, and findings of the hospital and central office morbidity, mortality, and sentinel events reviews are strictly confidential and are not subject to disclosure or discovery or introduction in evidence in any civil action, as specified in sections 1751.21. 2305.24. 2305.25. 2305.251. 2305.252. 2305.253. 2305.28. 5122.31. and 5122.32 of the Ohio Revised Code.
(1) Review and reporting process (see appendix A: flow chart of the morbidity, mortality, and sentinel event review procedure).
Immediately following a morbidity, mortality or sentinel event that meets the criteria defined under (A)(2)(a) through (A)(2)(f) of this rule, the hospital CEO/designee shall report the event to the ODMH hospital services (HS) deputy director/designee via phone or e-mail, and the hospital CCO/designee shall report the event to the ODMH medical director/designee via phone or e-mail. The RPH shall attempt to report the event to the patient and guardian, and shall attempt to notify the patient's family, if the patient has provided consent.
(b) Initial review bv RPH M&M:
An initial review shall be completed by the CCO/designee and at least two other hospital M&M committee members using the ODMH morbidity, mortality and sentinel event report form, section I (appendix B). The initial review shall be submitted to the HSM&M committee by noon of the second business day following the event or discovery of the event.
The purpose of the initial review is (1) to review events and circumstances preceding the event; (2) to identify immediate action needed to reduce risk of a similar event occurring in the immediate future; (3) select the appropriate level of analysis to complete a full review (intense analysis or root cause analysis); and (4) to determine information to be gathered to complete the full review.
The HSM&M committee designees shall review the description of actions provided by the hospital CCO and may issue an M&M initial alert to all RPHs.
(c) Full review bv RPH M&M:
The hospital CEO/CCO/designee shall determine whether the event is a reviewable sentinel event, morbidity/mortality event, or other sentinel event.
(i) For reviewable sentinel events, a thorough and credible root cause analysis shall be conducted by the RPH M&M committee and submitted to the HSM&M committee within forty-five days of the event or its discovery using the ODMH morbidity, mortality, and sentinel event report form.
The deputy director of HS/ODMH medical director/designee shall determine whether to report the event as a sentinel event to the joint commission; or as a restraint-related death to CMS.
(ii) For morbidity and mortality events that do not meet criteria described in (B)(5) of this rule, an intense analysis shall be conducted and submitted to the HSM&M committee within thirty days of the event or its discovery using the ODMH morbidity, mortality, and sentinel event report form, or the CCO/CEO may direct the completion of a root cause analysis.
At least one root cause analysis of a morbidity, mortality, or sentinel event must be conducted annually.
(iii) For all other sentinel events not described in (D)(1)(C)(i) or (D)(1)(c)(ii) of this rule, a criminal and/or administrative investigation shall occur in accordance with RPH internal policy.
The RPH M&M committee may assign parts of the investigation to quality assurance subcommittees which include staff at all levels closest to the issue(s) and those with decision-making authority.
It is understood that care provided outside of the RPH. (e.g.. general hospital care, group home, own home, etc.l may not be accessible to the RPH for review.
(d) Review upon receipt of death certificate, and coroner's report (if available).
If the event is a death, a death certificate and coroner's report (if available) shall be reviewed, and its impact, if any, on the findings of the RPH M&M committee shall be noted on the ODMH morbidity, mortality, and sentinel event report form, section IV. If the coroner's report is not available at the time of the full review, a follow-up review by the RPH M&M committee is to be completed within seven days of the receipt of the coroner's report. An amended root cause analysis or intense analysis form shall be completed as indicated.
(e) Status of risk reduction plan.
Progress on each risk reduction strategy identified in the full review shall be reported on a quarterly basis using the ODMH morbidity, mortality, and sentinel event report form, section VI. A status report is due within thirty days of the end of each quarter, until the intervention plan is complete.
(a) The initial review shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section I. by noon of the second business day following the event or discovery of the event.
If an intense analysis is required, it shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section III, within thirty days of the event or discovery of the event.
If a root cause analysis is required, it shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section III and IV. within forty-five days of the event or discovery of the event. A copy of the death certificate and coroner's report (if available^) and an amended intense analysis or root cause analysis form shall be submitted within seven days after it is received by the RPH.
Status reports are due within thirty days of the end of each quarter using the ODMH morbidity, mortality, and sentinel event report form, section VI. until the intervention plan is complete.
(b) The ODMH HSM&M committee shall review all reports submitted, and may request that the RPH further refine the analysis. Based on the findings of the full review, the ODMH HSM&M committee may issue an M&M safety alert to other RPHs to communicate recommendations for patient safety, system improvement, and risk management.
(3) Quality assurance review at the RPH and HS system levels.
(a) The RPH quality assurance and/or risk management committees shall review hospital morbidity, mortality, and sentinel event reports on a regular basis in order to evaluate the effectiveness of the improvements made in the system, and further refine the system as indicated.
(b) The ODMH HSM&M committee shall conduct analyses of quality assurance reports to assure overall system improvements are implemented, that implementation is evaluated, and that training needs are incorporated into educational planning for the hospitals.
(c) An annual report concerning morbidity, mortality, and sentinel events shall be submitted to the ODMH director bv the ODMH HSM&M committee.